Transvaginal mesh has been recalled numerous times. This medical device is used to treat pelvic organ prolapse. I would not say that the FDA is completely at fault. The FDA did approve the product but we are not certain of the other factors that went into the decision.
Often times, some of the trials the devices undergo are not as extensive as the public would like, but items are fast tracked when there is a high need. Another factor that is considered is whether the results outweigh the side effects. Additionally, the clinical trials are tested on a diverse population, but there is no way to predict all outcomes the device will face with every individual it comes into contact.
For example, the J&J COVID-19 vaccine was approved then recalled after adverse side effects were revealed. The vaccine was pushed through FDA approval quickly to meet the public need. Every person, who received the vaccine, did not experience bad side effects, but enough people did for them to recall it. Was the FDA at fault? Did the public outcry play a part in the rapid approval process?
I cannot place the blame solely on the FDA.
I do not think that everything that causes a recall I because of the FDA. Things such as sterilization comes from responsibility of the company. It is up to the company to make sure the things that they manufacture and distribute is of quality, safety, and efficacy. Checking for sterilization debris is essential, but the FDA does not work at the facility all day every day, so they can't guarantee that the company's workers are following protocol and double checking.
The U.S. FDA has the job of preserving the public health of all U.S. consumers through the regulation of a potential health risks; which includes human and veterinary drugs, biological products, medical devices, food, cosmetics, and products that put out radiation. While the FDA's mission is to look out for consumers, many previously-approved items have resulted in recalls, long-term injuries, and lawsuits, calling into question the efficacy of their approval process.
Over the course of the last year, the FDA recalled Smiths Medical's Computerized Ambulatory Delivery Device pump, which is a combination product which delivers a drug at a programmed time and dose. This device was recalled due to issues with dosing accuracy in which blockage would occur in the tube, resulting in under-dosing or over-dosing. This recall is an example of a quality recall in which the functionality of the device has shown to potentially yield inaccurate dosage. The FDA labeled this recall as Class I, which is the highest degree of a health risk. Different types of recalls may include issues with quality, and sterility as well as changes in regulations over time. In this case, the FDA would be considered responsible since they approved the use of the device. All potential failure modes should be assessed and the potential risk should be evaluated to determine whether the device is ready to be approved or if further modifications need to occur.
Hello,
While the FDA conducts extensive testing and requires substantial documentation for approval, recalls do occur. Several medical products have experienced recalls over the years, including both drugs and devices. These recalls happen for various reasons, often related to safety concerns or unexpected adverse effects. For instance, some drugs may be recalled due to newly discovered side effects that were not apparent during initial testing, or because of manufacturing issues that may have compromised product quality. Similarly, medical devices might be recalled if they malfunction, pose a risk to patients, or fail to perform as intended. In many cases, the FDA acts responsibly by issuing recalls when necessary to protect public health. Their rigorous approval process is designed to minimize the risk of recalls, but it is impossible to predict all potential issues in advance. Recalls are often the result of unforeseen complications that may not have been evident during the initial stages of testing and approval.
The FDA has a very important role in regulating and approving products, but it cannot always predict long-term side effects that only appear after products are used widely in real life. Recalls often happen because of unexpected risks, manufacturing issues, or information discovered through post-market monitoring.
For example, Vioxx, a pain and inflammation drug, was withdrawn from the market in 2004 after studies showed it could increase the risk of heart attacks and strokes. This case highlights how some problems only become visible after a product reaches many patients.
I think the FDA shares some responsibility, but companies also need to actively track and report on the safety of their products after approval. Ongoing testing, transparency, and communication are necessary to protect patients. Overall, I believe recalls don’t always mean the FDA failed, but rather that safety is a continuous process that requires effort from both regulators and manufacturers.
Recalls serve as a reminder that no system is flawless, even with FDA approval, and are a challenging yet crucial aspect of the medical device lifecycle. Some well-known examples are insulin pumps, which were recalled due to software errors that resulted in inaccurate dosages, and hip implants, where specific metal-on-metal designs were recalled because metal particles wore off and caused tissue injury. Long-term usage in sizable populations exposed issues that early clinical trials and pre-market testing were unable to completely identify, which is why recalls occurred in both situations. Although it's simple to blame the FDA, I believe the larger picture is that, although it offers a crucial baseline for safety and efficacy, it is unable to predict every potential consequence after a device is used by millions of people. However, it begs the question of how much accountability the FDA has against the manufacturer when problems occur. Should businesses assume greater responsibility for tracking the long-term performance of their gadgets, or should the FDA impose more stringent post-market surveillance regulations?
After doing some research, I found that Medtronics Sprint Defibrillator leads were recalled in 2007 after reports of wire fractures that caused device failure. After being approved and widely used, reports began to surface of wire fractures, which could prevent the device from working properly or cause it to deliver inappropriate shocks. There was a reported 665 failures and five reported deaths. Medtronic issued a voluntary recall of the leads, but because they were already implanted in thousands of patients, removal carried significant surgical risks since it would form scar tissue. The incident also raised concerns about the FDA’s approval process, as the leads were approved through a faster review pathway with limited clinical testing.
A product that was recently recalled is Zantac. This is a heartburn drug and it was recalled in 2019 because of a cancer causing chemical called NDMA. This became clear after testing when it was in market. I do not believe that the FDA is completely responsible, I think the company manufacturing the drug should have done more testing and research t make sure it was safe.
FDA approval does not always mean a device is truly safe. There have been high profile cases, such as metal-on-metal hip implants and implantable cardioverter defibrillators, where thousands of patients were harmed before recalls were issued. In many of these situations, warning signs appeared early, but the FDA either relied too heavily on manufacturer reported data or was slow to act.
Part of the issue is that the FDA review process often depends on limited premarket testing, sometimes with small sample sizes and short followup periods. Rare or long term complications can easily be missed, but once the device is on the market, problems scale up quickly. Perhaps the FDA’s post market surveillance has been too reactive however, there is also a fine balance between necessary demand and zealous output that should be considered. As in- sometimes it may be beneficial to quickly mediate an issue with a product as the potential of saving lives far outweighs the potential unknown future issues. However, I believe this to be rare.
As there are some other discussions that have similar topics involving safety of an approved medical device or drug, again it's important to see that safety is not 100% guaranteed, but the benefits do outweigh the risk of what has been approved. An example would be the CPAP and BiPAP (obstructive sleep apnea treatment devices) by Philips Respironics, which had affection many users. The issue in question related to the abatement foam inside the machine (polyester based polyurethane), which was originally intended to make the device both quieter and more comfortable. Over time, the foam degraded and caused a release in particles that would go into the airflow pathway (since the device is made for pushing air during apnea events) that would affect patients over time as reported health concerns came in. While the device cleared the FDA, the long term degradation effects of the foam wasn't fully observed during testing or pre-market review. I believe the manufacture holds the primary responsibility, but the FDA does also hold some form of it as well. This should have been analyzed in some way as the device is pushing air INTO a patient and usually CPAP devices are a life long treatment. I myself am a user of one, and after reading this story I'll probably look into my own device (from Resmed) and see if there needs to be any update or issues with my own CPAP.
When it come to recalls after a device that has been placed on to the market, I think that most of the fault comes from the company itself as they could have changed as the product was placed onto the market. But is not to say the FDA couldn't be at fault as well, but they do have a very lengthy and intense process in which allows for medical devices and medicines to be placed into market as they require an extensive amount of test as well. Now for what can cause for the recall to happen, it can be caused by a multitude of things, but some of the common causes are due to compromised sterile environment, machine malfunctioned, or etc. Most of the reasons are due the fault of the company as they didn't realize that the parts used or thing used would result in the product to fail or cause adverse effects due to these things. The FDA approving it could have been based off the testing going well and then realized that a batch afterward could have been just a batch of lemons and not the same quality as the product they wanted to release and just have to pull the product back or pay for a replacement for patients as well.
